Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - isturisa

Document Subject

Generated Narrative: MedicinalProductDefinition mp13bb467fc3daebcc72e614a634466540

identifier: http://ema.europa.eu/identifier/EU/1/19/1407/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Isturisa 1 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-13bb467fc3daebcc72e614a634466540

identifier: http://ema.europa.eu/identifier/EU/1/19/1407/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - isturisa

Attesters

What is in this leaflet

1. What Isturisa is and what it is used for
2. What you need to know before you take Isturisa
3. How to take Isturisa
4. Possible side effects
5. How to store Isturisa
6. Contents of the pack and other information

What Isturisa is Isturisa is a medicine that contains the active substance osilodrostat.

What Isturisa is used for Isturisa is used in adults to treat endogenous Cushing s syndrome, a condition in which the body produces too much of a hormone called cortisol. Too much cortisol may lead to a variety of symptoms such as weight gain (particularly around the waist), a moon-shaped face, bruising easily, irregular periods, excessive body and facial hair, and generally feeling weak, tired or unwell.

How Isturisa works Isturisa blocks the main enzyme that makes cortisol in the adrenal glands. The effect of this is to decrease the over-production of cortisol and improve the symptoms of endogenous Cushing s syndrome.

Do not take Isturisa:

• if you are allergic to osilodrostat or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions Talk to your doctor or pharmacist before taking Isturisa.

If any of the following apply to you, tell your doctor before taking Isturisa:

• if you have a heart disorder or a heart rhythm disorder, such as an irregular heartbeat, including a condition called prolonged QT syndrome (QT interval prolongation).
• if you have a liver disease; your doctor may need to change your dose of Isturisa.

Contact your doctor immediately if you have two or more of these symptoms during your treatment with Isturisa. This may indicate that you have adrenal insufficiency (low cortisol levels):

• weakness
• light-headedness
• tiredness
• lack of appetite
• nausea (feeling sick)
• vomiting

Tests before and during treatment Your doctor will test your blood and/or urine before you start treatment and regularly during treatment. This is to detect any possible abnormalities in your magnesium, calcium and potassium levels and also to measure the levels of cortisol. Depending on the results, your doctor may change your dose.

This medicine may have an unwanted effect (called QT prolongation) on the function of the heart. Your doctor will therefore also check for this effect by performing an electrocardiogram (ECG) before you start treatment and during treatment.

If your Cushing s syndrome is caused by a benign tumour (called adenoma) in the pituitary gland, your doctor may consider stopping your treatment if a pituitary scan shows that the adenoma has expanded into neighbouring regions.

Children and adolescents This medicine is not recommended for patients aged under 18 years. This is because there is a lack of data in these patients.

Other medicines and Isturisa Tell your doctor if you are taking, have recently taken or might take any other medicines. It is particularly important that you mention any of the following medicines:

• medicines that may have an unwanted effect (called QT prolongation) on the function of the heart. These include medicines used for abnormal heart rhythm such as quinidine, sotalol and amiodarone; medicines used for allergies (antihistamines); antidepressants such as amitriptyline and drugs for mental health disorders (antipsychotics); antibiotics, including the following types: macrolides, fluoroquinolones or imidazole; and other medicines for Cushing s disease (pasireotide, ketoconazole)
• theophylline (used to treat breathing problems) or tizanidine (used to treat muscle pain and muscle cramps)

Pregnancy and breast-feeding This medicine should not be used during pregnancy or breast-feeding, unless your doctor has advised you to do so. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Contraception Women who could become pregnant should use an effective method of contraception during treatment and for at least one week after the last dose. Ask your doctor about the need for contraception before you start taking Isturisa.

Driving and using machines Dizziness and tiredness may occur during treatment with Isturisa. Do not drive or operate machines if you get these symptoms.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The usual starting dose is two 1 mg tablets twice a day (about every 12 hours). Patients of Asian ancestry and patients with liver disease may need a lower starting dose (one 1 mg tablet twice a day).

After you have started treatment, your doctor may change your dose. This will depend on how you respond to the treatment. The highest recommended dose is 30 mg twice a day.

Isturisa tablets are taken by mouth and can be taken with or without food.

If you take more Isturisa than you should If you have taken more Isturisa than you should and you feel unwell (for example if you feel weak, light-headed, tired or sick, or if you have to vomit), or if someone else accidentally takes your medicine, contact a doctor or hospital for advice immediately. Medical treatment may be needed.

If you forget to take Isturisa Do not take a double dose to make up for a forgotten dose. Instead, just wait until it is time for your next dose and take that at the scheduled time.

If you stop taking Isturisa Do not stop taking Isturisa unless your doctor tells you to. If you stop your treatment with Isturisa, your symptoms may come back.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects may be serious. Please take particular note of the following:

• Tell your doctor immediately if you experience a heart disorder or heart rhythm disorder, such as a fast and irregular heartbeat, even when you are at rest, heart palpitations, blackouts or fainting (this could be a sign of a condition called QT prolongation, a side effect that may affect up to 1 in 10 people).
• Tell your doctor immediately if you have two or more of these symptoms: weakness, light-headedness, tiredness (fatigue), lack of appetite, nausea (feeling sick), vomiting. This may indicate that you have adrenal insufficiency (low cortisol levels), a side effect that may affect more than 1 in 10 people. Adrenal insufficiency occurs when Isturisa lowers the amount of cortisol too much. It is more likely to occur during periods of increased stress. Your doctor will correct this by using a hormone medicine or by adjusting the dose of Isturisa.

Very common side effects (may affect more than 1 in 10 people):

• vomiting

• nausea (feeling sick)

• diarrhoea

• abdominal pain

• tiredness (fatigue)

• build-up of fluid leading to swelling (oedema), particularly of your ankles

• abnormal blood tests (increased levels of testosterone, increased levels of adrenocorticotrophic hormone, also known as ACTH, low levels of potassium)

• decreased appetite

• dizziness

• myalgia (muscle pain)

• arthralgia (joint pain)

• headache

• rash

• low blood pressure (hypotension)

Common side effects (may affect up to 1 in 10 people):

• fast heartbeat (tachycardia)
• general feeling of being unwell (malaise)
• abnormal results of liver function tests
• fainting (syncope)
• excessive facial or body hair growth (hirsutism)
• acne

Reporting of side effects If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

Do not store above 25 C.

Store in the original package in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Isturisa contains

• The active substance is osilodrostat. Each film-coated tablet contains 1 mg osilodrostat, 5 mg osilodrostat or 10 mg osilodrostat.

• The other ingredients are:

• In the tablet core: microcrystalline cellulose, mannitol, croscarmellose sodium, magnesium stearate, colloidal anhydrous silica.

• In the film coating: hypromellose, titanium dioxide (E171), iron oxides (E172, see below), macrogol and talc.

• Isturisa 1 mg film-coated tablets contain iron oxide yellow and iron oxide red.

• Isturisa 5 mg film-coated tablets contain iron oxide yellow.

• Isturisa 10 mg film-coated tablets contain iron oxide yellow, iron oxide red and iron oxide black.

What Isturisa looks like and contents of the pack Isturisa is available in packs containing 60 film-coated tablets.

The 1 mg tablets are pale yellow, round, unscored and debossed with 1 on one side. The approximate diameter is 6.1 mm.

The 5 mg tablets are yellow, round, unscored and debossed with 5 on one side. The approximate diameter is 7.1 mm.

The 10 mg tablets are pale orange brown, round, unscored and debossed with 10 on one side. The approximate diameter is 9.1 mm.

Marketing Authorisation Holder Recordati Rare Diseases Immeuble Le Wilson 70 avenue du G n ral de Gaulle 92800 Puteaux France

Manufacturer Millmount Healthcare Ltd
Block 7, City North Business Campus, Stamullen,
Co. Meath, K32 YD60,
Ireland

Recordati Rare Diseases Immeuble Le Wilson 70 avenue du G n ral de Gaulle 92800 Puteaux France

Recordati Rare Diseases Eco River Parc 30 rue des Peupliers 92000 Nanterre France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Recordati T l/Tel: +32 2 46101 Lietuva Recordati AB. Tel: + 46 8 545 80 vedija

Recordati Rare Diseases Te .: +33 (0)1 47 73 64

Luxembourg/Luxemburg Recordati T l/Tel: +32 2 46101 Belgique/Belgien esk republika Recordati Rare Diseases Tel: +33 (0)1 47 73 64 Francie

Magyarorsz g Recordati Rare Diseases Tel: +33 (0)1 47 73 64 Franciaorsz g Danmark Recordati AB. Tlf: + 46 8 545 80 Sverige

Malta Recordati Rare Diseases Tel: +33 1 47 73 64 Franza Deutschland Recordati Rare Diseases Germany GmbH Tel: +49 731 140 554 0

Nederland Recordati Tel: +32 2 46101 Belgi

Eesti Recordati AB. Tel: + 46 8 545 80 Rootsi

Norge Recordati AB. Tlf: + 46 8 545 80 Sverige

Recordati Hellas : +30 210 6773 sterreich Recordati Rare Diseases Germany GmbH Tel: +49 731 140 554 0 Deutschland

Espa a Recordati Rare Diseases Spain S.L.U. Tel: + 34 91 659 28 Polska Recordati Rare Diseases Tel: +33 (0)1 47 73 64 Francja

France Recordati Rare Diseases T l: +33 (0)1 47 73 64 Portugal Jaba Recordati S.A. Tel: +351 21 432 95 Hrvatska Recordati Rare Diseases T l: +33 (0)1 47 73 64 Francuska

Rom nia Recordati Rare Diseases Tel: +33 (0)1 47 73 64 Fran a Ireland Recordati Rare Diseases T l: +33 (0)1 47 73 64 France

Slovenija Recordati Rare Diseases Tel: +33 (0)1 47 73 64 Francija sland Recordati AB. Simi: + 46 8 545 80 Sv j

Slovensk republika Recordati Rare Diseases Tel: +33 (0)1 47 73 64 Franc zsko Italia Recordati Rare Diseases Italy Srl Tel: +39 02 487 87 Suomi/Finland Recordati AB. Puh/Tel : +46 8 545 80 Sverige

Recordati Rare Diseases : +33 1 47 73 64

Sverige Recordati AB. Tel : +46 8 545 80 Latvija Recordati AB. Tel: + 46 8 545 80 Zviedrija United Kingdom (Northern Ireland) Recordati Rare Diseases UK Ltd. Tel: +44 (0)1491 414This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: